Under IMed's Lens - June 2024

New whitepaper exploring regulatory challenges for AI and ML in medical devices and digital health products

From wearable sensors that monitor vital signs to AI-powered diagnostic tools, the range of innovations is vast and promises to revolutionize healthcare delivery. Regulators are thus striving to keep pace with technological advancements, while addressing concerns regarding data security, potential bias and safety impacts possible from poorly performing clinical software tools.?

As a result, navigating the evolving regulatory landscape poses challenges for manufacturers implementing AI and ML, especially as digital health solutions can blur the lines between medical devices and non-medical tools. Understanding the expectations of regulators and assessing the strategic considerations necessary for incorporating AI into a device may also prove key to ensuring a smoother launch into the market.

“As standards and requirements evolve, navigating nebulous definitions and requirements correctly can be the make-or-break for new devices that pave the way for transformative digital health solutions.” comments Leeanne Baker, Managing Director and Senior QA/RA Consultant at IMed Consultancy.

Our newest free whitepaper that sheds light on the complex and confusinig regulatory state of play for AI and Machine Learning-powered medical devices internationally is available here, while you can find all our other whitepapers on our resources page!

Jonathan Ripley steps into the Managing Director role at IMed Consultancy

As Leeanne Baker focuses on international strategy as IMed Group’s new Chief Executive Officer

We’re pleased to announce Jonathan Ripley is the new Managing Director of IMed Consultancy. The previous MD, Leeanne Baker , will be focusing on a more strategic Group role as the new Chief Executive Officer of IMed as the Group expands.?

"I am honoured to step into the role of Managing Director at IMed Consultancy. I am committed to maintaining the high standards of regulatory support and consultancy that our clients expect. Together with our talented team, we will continue to navigate the complex regulatory landscape to ensure our clients' success,” said Jonathan Ripley.?

"I am thrilled to take on the role of CEO at IMed Group," comments Leeanne Baker. "Our objective remains to support our clients in delivering safe and effective medical devices to the market[JR1]?. I look forward to driving our strategic vision forward and continuing to build on our success."?

Our June blogs ??

Leveraging your 510(k) in the Saudi Arabia regulatory landscape

Saudi Arabia, officially known as the Kingdom of Saudi Arabia (KSA), presents a compelling opportunity for medical device manufacturers. The market value for medical devices in Saudi Arabia is expected to reach US$6.55bn in 2029, and US$8.30bn in 2029, with a CAGR of 4.85%, driven by government initiatives to enhance healthcare infrastructure and services. Jonathan Ripley, IMed’s Managing Director, delves into this interesting market in our latest blog. ?? Key Highlights:

• ?Market potential: Saudi Arabia's medical device market is projected to hit $6.55bn by 2029.
• Regulatory overview: understand the stringent requirements of the Saudi Food and Drug Authority (SFDA).
• Strategic tips: learn how to classify devices, prepare documentation, and engage local representatives for successful market entry.

Best foot forward – Pros and cons of entering the EU market first

Welcome back to our blog series dedicated to International Market Entry! IMed’s team will look at three major markets for medical devices- the EU, the UK and the USA- highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions and successfully expand the global presence of their products.

This final instalment will focus on the European medical devices market. Read more on our blog and remember to follow IMed Consultancy Ltd!

?In other news…??

As presenters on Workshop 3 of the @TBAT Innovation Challenge 2024, we’re excited to announce that the application window is now open!??

Who can apply for the Innovation Challenge??

• Startups: UK Businesses three years old or younger?
• Aspiring Entrepreneurs: Those who are seeking to launch a business in the UK
• UK Businesses over three years old that are still heavily involved in R&D or looking to introduce new technology
• Technology-based Businesses: Your business must offer a technology-based product or service, showcasing innovative solutions??

?Full prize fund details:?The Innovation Challenge Prize Package - TBAT Innovation?

The application window will close on the 18th of August 2024.

The Top 10 shortlisted applicants will be invited to pitch at the Finalist Showcase Event on the evening of 9th October 2024, where a winner will be announced.

If you would like further details on applying for the Innovation Challenge, please visit:?Application Process - TBAT

Jo Rudzki Sam Stephens

? On August 14th Al Mills , our Business Development Director, will be presenting to Innovate UK Business Support via Leicester Chamber of Commerce on how early engagement with regulatory can help shape a commercial strategy for MedTech start-ups. Follow her for more info!

? On August 18th you’ll find IMed’s Business Development Director Al Mills at Medilink Midlands ’ Summer Networking event, let us know if you’re attending in the comments!

? On August 18th Al Mills will also attend DiNG DiNG - Design and Innovation Nottingham July meetup, an evening of practical talks and discussions about design research and innovation! Find out more and register for free here.